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The Canopy Cancer Collective Clinical Registry Protocol

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects health records and information about tissue and other samples from people with gastrointestinal (GI) cancers, which affect the digestive system. It is for people treated at Canopy centers or their partner sites. It does not test drugs or devices; the goal is to support future research and improve cancer care.

The Canopy Cancer Collective Clinical Registry Protocol Non-Interventional Data and Sample Collection Registry Protocol Number of study sites 15 Study Design - Observational, registry Primary Objective To systematically collect and store comprehensive data on gastrointestinal cancer patients, encompassing both their past medical history and future clinical experiences, to address specific future research questions related to these malignancies, to establish and share best practices, and to support quality improvement initiatives focused on enhancing patient care and outcomes. Secondary Objective(s) 1. Leverage the collective to increase access to molecular profile and biomarker (ctDNA) matched clinical trials across the treatment trajectory. 2\. Use real world data and patient reported outcomes to improve patient care throughout the treatment trajectory. Research Procedure(s) Collection of clinical and outcome data and cataloging and facilitating access to physical biological specimens and their associated data for future research purposes. Drugs/Devices used on Study None Study Population Patients with diagnosis of gastrointestinal (GI) cancers who seek care at one of the canopy centers and/or their affiliates Sample Size Up to 30000 patients in the prospective component Up to 70000 subjects will be enrolled on the retrospective component Study Duration for Individual Participants Anticipated to be at least 1 year Study Specific Abbreviations AE: Adverse Event CEC: Clinical Events Committee CT: Computed Tomography iCCA: Intrahepatic cholangiocarcinoma MRI: Magnetic Resonance Imaging OS: Overall Survival PFS: Progression Free Survival

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both groups: Must be at least 18 years old, or 19 in Alabama or Nebraska, or 21 in Puerto Rico.
  • Both groups: Must have GI cancer confirmed by a tissue test.
  • Past-records group: Must have been seen at the study site in the 20 years before the study opened.
  • Past-records group: Must have died or had no contact with the site for more than 1 year since the last visit.
  • New-enrollment group: You or your legal representative must understand the study and agree to sign a consent form.
  • New-enrollment group: You or your legal representative must agree to collection of health data and information about stored tissue and extra samples left over from routine care.

Who can't join

  • Past-records group: The medical record says use of the person's health information is restricted.
  • New-enrollment group: People in prison will not be asked to join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Retrospective Cohort: 1. Must have reached the age of majority in the jurisdiction where enrolled (18 years; Alabama/Nebraska 19; Puerto Rico 21). 2. Must have histologically proven GI cancer seen at the site within the 20 years preceding activation, and are: 1. Deceased, or 2. Lost to follow-up ( \>1 year lapse in contact since last visit). Prospective Cohort: 1. Must have reached the age of majority in the jurisdiction where enrolled (18 years; Alabama/Nebraska 19; Puerto Rico 21). 2. Must have histologically proven Gastrointestinal (GI) cancer. 3. Patient or legally authorized representative capable of understanding and willing to provide signed informed consent (assent if applicable). 4. Patient/Legally Authorized Representative (LAR) agrees to collection of clinical data and information available on archival tissue and subsequent excess specimens obtained as part of standard-of-care. Exclusion Criteria: Retrospective Cohort: 1\. Cases in which patient's medical chart denotes restricted use of health information. Prospective Cohort: 1\. Prisoners will not be approached for participation.

Study sites (10)

CA

FL

MD

NY

OH

TX

WA